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NCT01186770 · ClinicalTrials.gov registry record · Phase 3
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
A Phase 3 study of Opioid-induced Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 804
- Enrollment target
- 2
- Study locations
NCT01186770: Completed Phase 3 study of Opioid-induced Constipation, sponsored by Bausch Health Americas.
NCT01186770 is a Phase 3 study of Opioid-induced Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 804 participants, below the 7,071-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01186770, a Phase 3 study of Opioid-induced Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 804 participants
- Enrollment target
- 2
- Study locations
Study Summary
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.
Primary Outcome
RFBM was defined as a bowel movement without laxative use within 24 hours prior to bowel movement.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Methylnaltrexone
Study Locations (2)
North Carolina
- PRA International - Raleigh
- PRA, Intl. - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 804 participants |
| Start Date | 2010-09-01 |
| Est. Completion | 2011-09-08 |
| Phase | Phase 3 |
What the finished NCT01186770 record still lists
NCT01186770 is an interventional study that assigns participants to a tested intervention. The registered 804 participants enrollment target is mid-sized for trials with a published cap, below the 7,071-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Opioid-induced Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01186770 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01186770 about?
NCT01186770 is a clinical study titled "A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain". MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.
What is the current status of trial NCT01186770?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 804 participants. The study started on 2010-09-01. Estimated completion is 2011-09-08.
What conditions does trial NCT01186770 study?
This clinical trial studies the following conditions: Opioid-induced Constipation.
What interventions are being tested in trial NCT01186770?
The interventions under investigation include: Placebo (DRUG), Methylnaltrexone (DRUG).
Who is sponsoring clinical trial NCT01186770?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01186770 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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